San Possidonio, IT · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MBB | Bone Cement, Antibiotic | Class II | Orthopedic | 3 | 2025-09-15 |
| LOD | Bone Cement | Class II | Orthopedic | 2 | 2020-03-19 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class II | Orthopedic | 1 | 2023-03-23 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-09-15 | K252443 | SpaceFix Shoulder Spacer | MBB | Class II | Orthopedic |
| 2023-03-23 | K223441 | SpaceFlex Acetabular Cup | KWY | Class II | Orthopedic |
| 2021-02-17 | K202338 | SpaceFlex Shoulder | MBB | Class II | Orthopedic |
| 2020-08-13 | K201960 | SpaceFlex Knee - 80mm Size | MBB | Class II | Orthopedic |
| 2020-03-19 | K193061 | G3 40 Radiopaque Bone Cement | LOD | Class II | Orthopedic |
| 2020-03-19 | K193059 | G1 40 Radiopaque Bone Cement | LOD | Class II | Orthopedic |